Flucon 35 ml Suspension: Each 5 ml contains Fluconazole USP 50 mg.
Flucon is a triazole antifungal. It is a potent and selective inhibitor of fungal cylochrome P-450 dependent enzymes necessary for the synthesis of ergosterol.
Mode of action:
Flucon acts by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeast and fungi.
Pharmacokinetics:
Flucon is well absorbed following oral administration. Bioavailability of the oral form is 90%. Mean peak plasma concentration of 6.72 / ug ml have been reported in healthy subjects following 1-400 mg oral dose. Peak concentrations are reached within 1 to 2 hours of oral administration. The elimination phase half life ranges from 20 to 50 hours. Flucon is widely distributed and achieves concentration in joint fluid, saliva, sputum, vaginal fluids, and peritoneal fluid similar to those achieved in plasma. Concentration in the cerebrospinal fluid range from 50 to 90% of plasma concentrations. Protein binding is about 11%. 80% or more of Flucon is excreted unchanged in the urine. Flucon can be removed by dialysis.
Vaginal candidiasis, Oropharyngeal candidiasis, Systemic candidiasis & Cryptococcal infections, Tinea corporis, Tinea Cruris, Tinea Pedis, Pityriasis versicolor, Other Tinea infections, Onychomycosis etc.
Diagnosis.
Recommended Dosage:
Vaginal candidiasis.
3 tea spoonful (15 ml) as a single dose.
Oesophageal candidiasis.
4 tea spoonful (20 ml) in 1st day followed by 2 tea spoonful (10 ml) daily for 14-30 days.
Systemic candidiasis & Cryptococcal infections.
8 tea spoonful (40 ml) in 1st day followed by 4 tea spoonful (20 ml) daily for 28 days or longer based on clinical response.
Tinea corporis, Tinea cruris, Tinea pedis, Other Tinea infections.
3 tea spoonful (15 ml) weekly for 4-6 weeks.
Pityriasis versicolor.
8 tea spoonful (40 ml) as a single dose.
Onychomycosis.
3 tea spoonful weekly for 12 months.
Usually require maintenance therapy to prevent relapse.
Child over 1 year.
In Superficial Candidiasis.
1-2 mg/kg daily.
In Systemic Candidiasis & Cryptococcal infection.
3-6 mg/kg daily.
In serious life threatening infections upto 12 mg/kg daily has been given to children aged 5-13 years (Maximum 400 mg daily).
Age.
Average weight.
Dose/Day.
1 year.
9 kg.
½ tea spoonful (2.5 ml).
1-2 years:
12 kg.
1 tea spoonful (5 ml).
2-3 years:
14 kg.
1½ tea.
Pregnancy: Adverse foetal effects have been seen in animals only at doses ranging from 80 mg/kg with maternal toxicity. These levels are 20-60 times the recommended therapeutic use. Still fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the foetus. Lactation: Fluconazole is secreted in human milk at concentrations similar to plasma. Therefore, the use of fluconzole in nursing mother is not recommended.
Caution should be taken in renal impairment, pregnancy and breast feeding mother.
Drug Intetactions: Fluconazole acts by inhiviting fungal cytochrome P-450 enzymes. It is much less active against mammalian P-450 enzymes, still potential exists for interaction with drugs that are metbolized by P-450. a. Cyclosporin: Fluconazole significantly increasses Cyclosporin levels; b. Phenytoin: Fluconazole significantly increasses phenytoin levels; c. Anticoagulants: Fluconazole has shown to prolong prothrombin time in subjects receiving Warfarin; d. Oral hypoglycaemics: Fluconazole has been shown to prolong the serum half life of concomitantly administered However no adverse effect on serum glucose levels was seen; e. Rifampicin: Decreases levels of fluconazole; f. Oral contraceptives: No clinically significant interactions have been seen.
Over dosage: In case of overdose, supportive measures and gastric lavage should be instituted. If deemed necessary, a 3 hrs haemodialysis will decrease plasma levels by about 50%.
Keep out of reach of children. Store in a cool and dry place, protected from light.